E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome |
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E.1.1.1 | Medical condition in easily understood language |
Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028245 |
E.1.2 | Term | Multiple sclerosis |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the efficacy and safety of intravenous Polyethylene glycosylated (PEG)-liposomal prednisolone sodium phosphate (Nanocort) vs intravenous methylprednisolone treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis (RRMS) or in patients with CIS.
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E.2.2 | Secondary objectives of the trial |
To explore the levels of free prednisolone and prednisolone phosphate
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients who are eligible for inclusion will be female or male patients, 18 to 65 years of age (inclusive), who have a diagnosis of RRMS (per McDonald criteria, 2005) with dissemination in time and space or a diagnosis of CIS confirmed by MRI. Patients with CIS who only have optic neuritis will be excluded from this study, a maximum Expanded Disability Status Scale (EDSS) score of ≤ 6.0, who have new neurological symptoms or exacerbation of prior neurological symptoms of over 24 hours duration but <7 days duration, verified by neurological examination and who have signed an informed consent. |
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E.4 | Principal exclusion criteria |
Patients will be excluded from participation in the study who have -Primary progressive MS. -Secondary progressive MS without superimposed relapses. -Received systemic corticosteroids within 4 weeks of screening for treatment of MS or other conditions. If non-systemic steroids (topical, inhalation, ocular) are being used for other chronic inflammatory conditions, patients may be included at the discretion of the investigator after discussion with the medical monitor. -Known contraindications or hypersensitivity to parenteral steroids e.g. systemic infection such as mycoses or parasitoses, acute viral infections (herpes zoster, herpes simplex, varicella), hepatitis B surface antigen (HBsAg) positive chronic active hepatitis, immunisations within recent weeks, lymphadenitis after Bacille Calmette-Guérin (BCG) vaccination, history of psychiatric problems including prior steroid psychosis, gastroduodenal or -intestinal ulcer, uncontrolled hypertension, severe osteoporosis and narrow- and wide-angle glaucoma -Previous treatment with azathioprine, mitoxantrone, natalizumab, intravenous immunoglobulin or plasmapheresis in the last 6 months. -Women who are lactating, pregnant (positive pregnancy test at Screening), or planning to become pregnant during the course of the study. -Unwillingness to use reliable and acceptable contraceptive methods (e.g. implants, injectables, combined oral contraceptives, intrauterine devices [IUDs], sexual abstinence or vasectomised partner) throughout the study and till 3 months after last study medication administration except for female patients who are surgically sterile (post hysterectomy or at least 1 year post tubal ligation) or at least 2 years postmenopausal. -Any concurrent illness, disability or clinically significant abnormality that may affect the interpretation of clinical efficacy or safety data or prevent the subject from safely completing the assessments required by the protocol. - History of malignancy within the last 5 years with exception of basal cell skin carcinoma - Chronic diseases of the immune system, malignancies, acute pulmonary disease, cardiac failure, severe depression etc. or unstable medical conditions. -Cardiac pacemaker or any other type of metal implant or with any other contraindication for MRI (including known allergy to gadolinium). -Participation in another clinical study within 60 days of screening. - Recent history or suspicion of current drug abuse (including analgesic abuse) or alcohol abuse within the last 6 months prior to Screening. - Medical, psychiatric, cognitive, or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study. - Known history of diabetes mellitus. - History of any other than MS autoimmune conditions or immunodeficiency syndromes.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 8. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Change in gadolinium-enhanced T1-weighted lesions according to the McDonald criteria (2005) from Day 8 to Week 4. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
assessor-blinded, i.e. those who evaluate the study outcome are not informed the treatment |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |